BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL

    K Number: K884884 · Decision Jun 16, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    206

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    Basic Information

    Device Name
    OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL
    K Number
    K884884
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3495
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Porex Technologies Corp. of Georgia
    Date Received
    November 22, 1988
    Decision Date
    June 16, 1989
    Product Code
    ETA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETA Replacement, Ossicular Prosthesis, Total

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    Other Clearances by Porex Technologies Corp. of Georgia

    K Number Device Name
    K960859 MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES